EpilepsyREUNIENCT02877576
Single Neurons Responses During Visual Recognition in Epileptic Patients
A study testing Implantation of mixed intracerebral electrodes, Face detection and Face individualization in people with Epilepsy, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose is to evaluate specific capacities of face detection of individual neurons by comparison with their capacity of object detection in medial temporal lobe and ventral temporal cortex in epileptic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Implantation of mixed intracerebral electrodes, Face detection and Face individualization
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with temporal or occipito-temporal drug-resistant partial epilepsy, symptomatic, needing surgical treatment
- Patient having signed informed consent
- Patient affiliated to social security
- Patient having undergone preliminary medical examination
Who cannot join
- Persons under legal protection or incapable to consent
- Persons deprived of liberty by juridical or administrative decision
- Patient with severe visual disorders of neurological or ophthalmological origin
- Patients with infection risk according to doctor or surgeon
- Women without effective contraception
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
Louis MAILLARD, Pr contact
France1 site, 1 recruiting
- Recruiting
Service de Neurologie, Hôpital Central, CHRU de Nancy
Nancy
Jacques Jonas
Jean-Pierre Vignal
About this study
Official title: Study of Cerebral Mechanisms of Visual Recognition With Single-unit Recordings of Intra-cerebral Neurons in Epileptic Patients
The purpose is to evaluate specific capacities of face detection of individual neurons by comparison with their capacity of object detection in medial temporal lobe and ventral temporal cortex in epileptic patients.
Secondary purpose is to evaluate specific capacities of detection of known faces of individual neurons by comparison with their capacity of detection of unknown faces in medial temporal lobe and ventral temporal cortex in epileptic patients.
Read the detailed description
In this interventional study, patients explored with mixed intracerebral electrodes (micro and macro-contacts) will be presented sets of images (objects, unknown faces, famous faces). Spikes and Multi-Unit-Activity will be recorded and analyzed and compared between conditions.
- Conditions
- Epilepsy
- Being tested
- Implantation of mixed intracerebral electrodes, Face detection, Face individualization
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of mixed intracerebral electrodesProcedure or surgery
5 macro electrodes with micro electrodes are implanted in internal temporal structures (amygdala, anterior and posterior hippocampus, rhinal cortex, posterior para-hippocampal gyrus).
Each electrode has 8 microcontacts, each recording the activity of 0 to 3 neurons (activity of 0 to 120 neurons/patient).
Face detectionBehavioural
Visualization of images of 60 unknown faces and 60 objects that are not faces (object, house, scene, animal, plant, word, letter…). Each image is showed for 500 ms and separated from following image by black screen of 1500 ms. In order to keep patient attention on image, patient will be asked to push a button at color change of fixation cross in the centre of image.
Face individualizationBehavioural
Visualization of images of celebrities (persons known by patient), showed randomly. Each image is showed for 500 ms and separated from following image by black screen of 1500 ms. In order to keep patient attention on image, patient will be asked to push a button at color change of fixation cross in the centre of image.
Several celebrities are showed, with for each the presentation of 60 images different from that celebrity. 1 to 3 celebrities are showed (60 to 180 total images).
| Study group | Role | What they receive |
|---|---|---|
| Epileptic patient | Experimental | micro-electrode recordings interventions: Implantation of mixed intracerebral electrodes Face detection Face individualization Receives: Procedure: Implantation of mixed intracerebral electrodes; Behavioral: Face detection; Behavioral: Face individualization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of action potential (Difference of neuronal activity) generated successively by visual presentation of 60 photography of different unknown faces and 60 different objects
Activity (number of action potential) is recorded for each neuron before and after visualization of each image.
Measured: after electrode implantation, up to 12 days
Secondary outcomes (1)
Number of action potential (Difference of neuronal activity) generated by visual presentation of 60 photography of a known target face (familiar) and 60 photography of unknown faces (non familiar)
Activity (number of action potential) is recorded for each neuron before and after visualization of each image.
Measured: after electrode implantation, up to 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis MAILLARD, Pr, Principal investigator, Service de Neurologie CHRU de Nancy - Hôpital Central
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877576
- Sponsor's protocol ID
- 2015-A01951-48
- Acronym
- REUNIE
- Status last verified
- Jul 2020
- First submitted
- 19 Aug 2016
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Le Cam S, Jurczynski P, Jonas J, Koessler L, Colnat-Coulbois S, Ranta R. A Bayesian approach for simultaneous spike/LFP separation and spike sorting. J Neural Eng. 2023 Mar 31;20(2). doi: 10.1088/1741-2552/acc210.
PubMed 36881899
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cerebral Mechanisms of Visual Recognition With Single-unit Recordings of Intra-cerebral Neurons in Epileptic Patients
- ClinicalTrials.gov ID
- NCT02877576
- Acronym / sponsor ID
- REUNIE / 2015-A01951-48
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to evaluate specific capacities of face detection of individual neurons by comparison with their capacity of object detection in medial temporal lobe and ventral temporal cortex in epileptic patients.
Secondary purpose is to evaluate specific capacities of detection of known faces of individual neurons by comparison with their capacity of detection of unknown faces in medial temporal lobe and ventral temporal cortex in epileptic patients.
Detailed description
In this interventional study, patients explored with mixed intracerebral electrodes (micro and macro-contacts) will be presented sets of images (objects, unknown faces, famous faces). Spikes and Multi-Unit-Activity will be recorded and analyzed and compared between conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epileptic patient | Experimental | Procedure: Implantation of mixed intracerebral electrodes, Behavioral: Face detection, Behavioral: Face individualizationmicro-electrode recordings interventions: Implantation of mixed intracerebral electrodes Face detection Face individualization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with temporal or occipito-temporal drug-resistant partial epilepsy, symptomatic, needing surgical treatment
- Patient having signed informed consent
- Patient affiliated to social security
- Patient having undergone preliminary medical examination
Key exclusion criteria (6 listed)
- Persons under legal protection or incapable to consent
- Persons deprived of liberty by juridical or administrative decision
- Patient with severe visual disorders of neurological or ophthalmological origin
- Patients with infection risk according to doctor or surgeon
- Women without effective contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of mixed intracerebral electrodes5 macro electrodes with micro electrodes are implanted in internal temporal structures (amygdala, anterior and posterior hippocampus, rhinal cortex, posterior para-hippocampal gyrus). Each electrode has 8 microcontacts, each recording the activity of 0 to 3 neurons (activity of 0 to 120 neurons/patient). | Procedure or surgery | Epileptic patient |
| Face detectionVisualization of images of 60 unknown faces and 60 objects that are not faces (object, house, scene, animal, plant, word, letter…). Each image is showed for 500 ms and separated from following image by black screen of 1500 ms. In order to keep patient attention on image, patient will be asked to push a button at color change of fixation cross in the centre of image. | Behavioural | Epileptic patient |
| Face individualizationVisualization of images of celebrities (persons known by patient), showed randomly. Each image is showed for 500 ms and separated from following image by black screen of 1500 ms. In order to keep patient attention on image, patient will be asked to push a button at color change of fixation cross in the centre of image. Several celebrities are showed, with for each the presentation of 60 images different from that celebrity. 1 to 3 celebrities are showed (60 to 180 total images). | Behavioural | Epileptic patient |
Primary outcome
Number of action potential (Difference of neuronal activity) generated successively by visual presentation of 60 photography of different unknown faces and 60 different objects
Time frame: after electrode implantation, up to 12 days
Activity (number of action potential) is recorded for each neuron before and after visualization of each image.
1 secondary outcome
Number of action potential (Difference of neuronal activity) generated by visual presentation of 60 photography of a known target face (familiar) and 60 photography of unknown faces (non familiar)
Time frame: after electrode implantation, up to 12 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 36881899Le Cam S, Jurczynski P, Jonas J, Koessler L, Colnat-Coulbois S, Ranta R. A Bayesian approach for simultaneous spike/LFP separation and spike sorting. J Neural Eng. 2023 Mar 31;20(2). doi: 10.1088/1741-2552/acc210.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis MAILLARD, Pr contact
Louis MAILLARD, Pr principal investigator
Service de Neurologie CHRU de Nancy - Hôpital Central
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of mixed intracerebral electrodes, Face detection and Face individualization in people with Epilepsy, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louis MAILLARD, Pr (l.maillard@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of action potential (Difference of neuronal activity) generated successively by visual presentation of 60 photography of different unknown faces and 60 different objects (time frame: after electrode implantation, up to 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02877576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.